|
Schedule
|
84A
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Approval Number
|
9736
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Manufacturer
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Profit Royal Pharmaceutical Ltd.
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Approval Date
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8/20/2024
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Product Line
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RES-12-A, RES-12-B, RES-12-C, Surgical N95, Filtering Facepiece
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For Protection Against
|
N95, Surgical
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Service Time (minutes)
|
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Facepiece Type
|
Filtering Facepiece
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Is the respirator powered?
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Non-powered
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Number of Filters
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1
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Is the the filter replaceable?
|
No
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Filter Location
|
Filtering-facepiece
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Cartridge or Canister
|
|
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Number of cartridge or canisters
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0
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Location of cartridge or canisters
|
|
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Is the cartridge or canister replacable?
|
No
|
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Self-contained breathing apparatus (SCBA) Type
|
|
|
Supplied air respirator (SAR) Type
|
|
|
Self-contained breathing apparatus (SCBA) Use
|
|
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Airflow
|
|
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Breathing Gas
|
|
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Percentage of Oxygen in Breathing Gas
|
|
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Regulator Location
|
|
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Low Temperature (Celsius)
|
|
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Low Temperature (Fahrenheit)
|
|
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Exhalation Valve?
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No
|
|
Self Rescuer?
|
No
|
|
Is the approval obsolete?
|
No
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|
Private Label |
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|
Model
|
|
|
Rated Duration
|
|
|
Cylinder pounds per square inch gauge (PSIG)
|
|
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Chemical, biological, radiological and nuclear (CBRN) Approval Date
|
|
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Comments
|
FDA/NIOSH MOU 225-18-007
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